Virus Safety

In the biotech and pharmaceutical industries, maintaining virus safety is paramount to ensure the safety, efficacy, and regulatory compliance of products, especially those derived from biological sources. Our Virus Safety consultancy provides specialized support to help you develop, evaluate, and optimize robust virus safety strategies throughout your manufacturing process.

We offer comprehensive Donor Testing services, which are conducted following risk assessments that consider factors like donor origin and potential virus exposure. Our experts also perform Process Evaluations for Virus Removal to identify and mitigate viral risks, ensuring your production processes are secure and compliant.

For companies advancing into Continuous Manufacturing, we provide Virus Validation services to help verify that your systems effectively control and eliminate viral contaminants. We also specialize in the Evaluation of Virus Clearance Capacity, ensuring that your virus clearance processes are robust and aligned with the latest industry standards.

Our team delivers Expert Reports and thorough Biosafety Evaluations to support your regulatory submissions and internal quality assurance efforts. With our deep understanding of global regulations, we offer tailored Regulatory Guidance to help you navigate the complex landscape of virus safety compliance.

Partner with us to enhance your virus safety protocols, ensuring your products meet the highest standards of quality and safety while achieving successful regulatory approvals.

Katy Lorineau

Scientific Officer

Katy earned her Biotechnology degree from ENSTBB, the National School of Biomolecule Technology in Bordeaux, in 2003. She began her professional career at Oxxon Therapeutics in Oxford, UK, a company focused on therapeutic vaccines and immunotherapy (now part of Oxford Biomedica). During her time there, she developed and validated qPCR assays for the characterization of MVA and FPV viral vector vaccines.
In 2006, Katy joined ViruSure, where she contributed to the GLP studies and quality groups. Starting as a GLP Study Director, she later advanced to GLP Study Manager and eventually took on the role of Head of GLP Validation Studies. In 2024, she was promoted to Scientific Officer, reflecting her broad experience and leadership in the field of GLP studies.
Throughout her career, Katy has been an active participant in international virus and prion safety conferences, and she regularly supports GLP study trainings at ViruSure Workshops. Her extensive knowledge and commitment to advancing safety testing methodologies provide valuable insights to clients, ensuring robust and reliable results in each project.